BI 10773 Administered as Oral Solution to Healthy Male Volunteers

NCT02172274 | Completed Phase 1

• 1 other identifier: 1245.8
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to determine the pharmacokinetics of BI 10773 and total radioactivity including excretion mass balance, excretion pathways and metabolism following the oral administration of \[14C\] BI 10773

Conditions

Healthy

Outcome Measures

Primary Outcomes (18)

• Cmax (maximum concentration of the analyte in plasma)

  pre-dose and up to 144 hours after administration

• tmax (time from dosing to the maximum concentration of the analyte in plasma)

  pre-dose and up to 144 hours after administration

• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)

  pre-dose and up to 144 hours after administration

• AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity)

  pre-dose and up to 144 hours after administration

• λz (terminal rate constant in plasma)

  pre-dose and up to 144 hours after administration

• t1/2 (terminal half-life of the analyte(s) in plasma)

  pre-dose and up to 144 hours after administration

• MRTpo (mean residence time of the analyte(s) in the body after oral administration)

  pre-dose and up to 144 hours after administration

• CL/F (apparent/total clearance of the analyte(s) in plasma after an extravascular dose)

  pre-dose and up to 144 hours after administration

• Vz/F (apparent volume of distribution during the terminal phase λz after an extravascular dose)

  pre-dose and up to 144 hours after administration

• feurine,0-tz (amount of analyte excreted in urine over the time interval from 0 to the time of the last quantifiable data point in % of dose, additionally excretion within each sampling interval will be calculated)

  pre-dose and up to 168 hours after administration

• fefaeces,0-tz (amount of analyte excreted in faeces over the time interval from 0 to the time of the last quantifiable data point in % of dose, additionally excretion within each sampling interval will be calculated)

  pre-dose and up to 168 hours after administration

• CLR,0-tz (renal clearance of analyte)

  pre-dose and up to 168 hours after administration

• Individual concentration-time profiles of [14C] radioactivity in whole blood, plasma, urine, and faeces

  up to 8 days

• Individual concentration-time profiles of BI 10773 in plasma and urine

  up to 8 days

• Rate and extent of excretion mass balance based on the total radioactivity in urine and faeces

  up to 8 days

• Identification of major metabolites in urine, faeces, and plasma

  up to 8 days

• Cblood cell/Cplasma ratio of [14C]-radioactivity

  up to 8 days

• Measurement of the plasma protein binding of total [14C] radioactivity in human plasma samples ex vivo

  up to 8 days

Secondary Outcomes (6)

• Number of patients with abnormal findings in physical examination

  Baseline and within 6 days after discharge

• Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)

  Baseline, days 1, 2, 7 and within 6 days after discharge

• Number of patients with abnormal findings in 12-lead electrocardiogram (ECG)

  Baseline, days 1, 2, 7 and within 6 days after discharge

• Number of patients with abnormal changes in laboratory parameters

  Baseline, days 1, 2 and within 6 days after discharge

• Number of patients with adverse events

  Up to 22 days

Study Arms (1)

[14C]-BI 10773 - oral solution

EXPERIMENTAL

Drug: [14C]-BI 10773 - oral solution

Interventions

[14C]-BI 10773 - oral solution DRUG

[14C]-BI 10773 - oral solution

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males according to a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG (electrocardiogram), and clinical laboratory tests
• Age 18 to 55 years, inclusive
• Body mass index 18.5 to 29.9 kg/m2, inclusive
• Nonsmoker
• Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation

You may not qualify if:

• Any finding in the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal, psychiatric or neurological disorders (including all forms of epilepsy)
• Surgery of the gastrointestinal tract (except appendectomy)
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Subjects with Gilbert's Syndrome
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• Intake of drugs with a long half-life (\>24 hours) within one month prior to administration of the trial drug
• Use of prescription medication, over-the-counter drugs or herbal preparations within 14 days prior to administration of the trial drug
• Participation in another trial with an investigational drug within two months prior to administration of the trial drug or during the trial
• History or evidence of habitual tobacco or nicotine use within six months prior to administration of the trial drug
• Alcohol abuse (more than 60 g/day)
• Drug abuse in opinion of investigator
• Blood donation (more than 100 mL within four weeks prior to administration of trial drug or during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 24, 2014
• Study Start: June 1, 2008
• Primary Completion: July 1, 2008
• Last Updated: June 24, 2014

Record last verified: 2014-06